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Control Syringe

by Medical Specialties Intl., Inc.

510(k) K972655

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK972655 Date4 Nov 1997ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
IZI
Device Class
Class II
Regulation
21 CFR Part 892.1600
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Control Syringe is a medical device used in radiology procedures. It is part of a system designed for angiographic applications, allowing for precise control and administration of contrast agents during X-ray imaging procedures.

The Control Syringe is supplied as a Class II medical device with FDA 510K clearance (K972655). It is manufactured by Medical Specialties Intl., Inc. and is intended for single-use in clinical settings. The device is not specified as MRI compatible and should be stored according to the manufacturer's instructions.

Other devices from Medical Specialties Intl., Inc.

  • Hematology Control

    Class II

  • Sedratrol

    Class II

  • Hema-Trol Q-Check

    Class I

  • Manifold

    Class II

Questions

AI-generated answers, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Control Syringe used for?

    The Control Syringe is a medical device designed for angiographic applications in radiology procedures. It allows for precise control and administration of contrast agents during X-ray imaging procedures.

  • Is the Control Syringe single-use or reusable?

    The Control Syringe is intended for single-use in clinical settings. It should not be reused as per the manufacturer's instructions to ensure patient safety and device performance.

  • What is the regulatory status of the Control Syringe?

    The Control Syringe is a Class II medical device with FDA 510K clearance (K972655). It has been determined to be substantially equivalent to other devices in its class for its intended use.

  • How should the Control Syringe be stored?

    The Control Syringe should be stored according to the manufacturer's instructions. The device is not specified as MRI compatible, so storage should follow standard medical device protocols.